Transform data to communicate in the language of Regulatory Science. Learn to gain trust on your own drug product, you are manufacturing. Enter in a stringent world with confidence. Measure the shortcomings. Be clear to make your tomorrow certain.

1. Transform data
to communicate in the language of
Regulatory Science
Learn to gain trust on your own drug product, you are
manufacturing. Enter in a stringent world with confidence.
Measure the shortcomings. Be clear to make your
tomorrow certain.
2021
Common Technical Document (CTD)
OR Centre for Quality Sciences

2. Common Technical Document (CTD)
Next Generation CTD Momentum in the Era of Artificial Intelligence & Data Sciences
 What is the significance of course?
 What will be the learning outcome?
 Who will be eligible to attend the course?
 What will be the methodology?
 How efficiency of learning will be assessed?
 Who will be supervising the course?
 What will be the fee of the course?
 What will be the venue?
Module 1: Limitations of Design, Critical Points and Misconceptions in
Understanding CTD
Course ID: CTD-0121
When & Where: February 2021 in Karachi
Who can attend: At least two year experience in compilation of manufacturing data of
generic drugs development is required.
Fee: Rs.12,000/= per participant via bank.
Course Facilitators: Obaid Ali & Roohi B. Obaid and guest experts
Both are postgraduate of pharmaceutical sciences who received
extensive knowledge on pre-market submissions, compliance &
enforcement strategies, approaches, tools and standards, as well as post
marketing variations through advanced academic and professional
courses beside series of trainings of regulators from US-FDA, Health
Canada etc. They worked on different regulatory agency desks as
functional head including pre and post registration of drugs, compliance
and enforcement of manufacturing facility, governing policy, designing
initiatives, developing strategies and conducting trainings within the
country, regulatory agency and outside Pakistan.
Contacts: Write course ID “CTD-0121” for tracking to cqsciences@gmail.com.
WhatsApp. 03215150062
Fellowship Available: For deserving professionals. Write detail letter of interest and
justification of receiving fellowship. It will be kept confidential.
Please read, it may be of
your interest

3. Background: Common Technical Document (CTD) is certainly the language of
science in submission and review of drug applications for enhancement
of safety, efficacy and quality of drug products as well as reduction of
uncertainty. The expanding crisis of ability and passion for knowledge
on one hand, whereas, relying on years of experience instead of
knowledge driven wisdom on the other hand in the society is a real
challenge. Development of all stakeholders is inevitable for fair progress
of industry within and outside the country to avoid any surprise
uncertainty. The shrinking of space is rapidly proliferating in today’s
dynamic world of fastest communication and information. Although
resistance to change is somewhere well justified, but at the same time,
preparedness to achieve the highest standards will not lose anything and
will enrich with support of modern science for sure.
Centre wishes to trigger a platform where knowledge can be cultivated.
CTD and its expectations need to be sincerely assessed and there is no
reason to feel inability of compliance. We will be pleased to offer
assistance in the shape of training of individuals. The training will cover
background knowledge that became the reason of harmonized document
and lessons learned by US-FDA regulators on CTD, when applied with
question based review process of 21st
century. The real observations of
greater impact recorded by FDA have always been close to the circle of
our interest. Those observations will be focused and counter argument
with scenarios will be framed. Some real time recent case studies of FDA
covering complex products, complex manufacturing process and difficult
generics will be chosen to develop tutorials. These tutorials will be
capable to give an insight on expanding regulatory expectations. Brief
description of course facilitator & coordinator is given below.
Methodology: Lecture and discussion session will be held to keep thinking process up
and aligned with the objectives. Real international dossiers will be used
as mock during the sessions. However, it will be welcome if someone
brings data of a drug product (named as “X” or “Y”) on which he or she
has enough knowledge and experience. The same will be converted to a
real dossier fulfilling the expectations of the highest regulatory
environment. It will facilitate in gripping the knowledge.
Learning & Assessment: Participants’ assessment will be done on real time basis and dashboard
will be kept confidential and shared with the management.
Group Size: It will be kept small and not more than 25 participants in any case to
maintain direct supervision during the course.
Modules: This course will comprise of 10 modules. Each module will be covered
in one day session. There will be 15 to 40 days gap between two
modules.
International Engagements: Experts from all over the world will be engaged in different segments
throughout the course.